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The Important Role that Biopharmaceutics Plays in Accelerating Early-Phase Drug Development

Pharmaceutical Technology

Our chemists and formulation scientists review the properties of new drug candidates and “work their magic” to develop formulations that improve the exposure profile of the compound. How does bioavailability play a role in biopharmaceutics? Now fraction absorbed and bioavailability are often confused and used interchangeably.

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Quality first: How pharma can meet injectables demand while staying compliant

Pharmaceutical Technology

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry.

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Building CO2-neutral, defossilised supply chains for chemicals

European Pharmaceutical Review

Organic compounds are arguably the foundation of the pharmaceutical industry. All traditional small molecule pharmaceuticals include carbon building blocks” Organic compounds are arguably the foundation of the pharmaceutical industry. EFPIA White Paper on Circular Economy, June 2020. Recycling of medical plastics.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2. The results of the risk assessment are used to define experiments.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2. The results of the risk assessment are used to define experiments.

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). These new operating models can help enable and accelerate the efforts of Pharma 4.0™